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Vascular AneurysmPLIANTIINCT03606083

Registry in Patients With Aorto-iliac or Iliac Aneurysms

An observational study of Vascular Aneurysm, run by JOTEC GmbH at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The PLIANT II registry is undertaken to examine the real-world outcome after treatment of consecutive patients with uni- or bilateral aorto-iliac or iliac aneurysms using the E-liac Stent Graft System. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Vascular Aneurysm
What is being tested?
Endovascular repair
Type of treatment
Medical device
How many people
298 participants
Where
1 siteGermany
Study dates
15 Jul 2018to 31 Oct 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Male and female patients with uni- or bilateral aorto-iliac or iliac aneurysm, treated with the E-liac Stent Graft System.

Who may be able to join

  • Age between 18 and 85 years
  • Patient must have an aorto-iliac or iliac aneurysm
  • Patient must have a unilateral or bilateral iliac aneurysm
  • Patient´s anatomy must be suitable for stent graft placement on preoperative angio CT scan
  • Patient must be available for the appropriate follow-up times for the duration of the study
  • Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to intervention

Who cannot join

  • Female of child bearing potential
  • Patients with ruptured iliac aneurysms
  • Patients with juxtarenal, pararenal or suprarenal aneurysms
  • Patients pretreated with Nellix (Endologix) or Altura (Lombard Medical)
  • Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
  • Patient with malignancy needing chemotherapy or radiation
  • Patients with life expectancy of less than 3 years
  • Patient minor or under guardianship

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia, 50937

Other trials in Germany

About this study

Official title: Prospective Multicenter Registry to Examine the Real-world Performance of the E-liac Stent Graft System for Treatment of Uni- or Bilateral Aorto-iliac or Iliac Aneurysms

The PLIANT II registry is undertaken to examine the real-world outcome after treatment of consecutive patients with uni- or bilateral aorto-iliac or iliac aneurysms using the E-liac Stent Graft System.

Read the detailed description

In this study, patients will be observed who receive one or two E-liac Stent Graft(s) for aorto-iliac or iliac aneurysms. The E-liac Stent Graft(s) will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the E-liac Stent Graft System. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before intervention and before data are being collected.

The period of data collection will be 60 months starting from the intervention for each patient. 100% verification of patient informed consent and essential study documents will be performed at each study site. 60% of patient´s source documentation will be randomly monitored.

Being tested
Endovascular repair
Keywords
aorto-iliac, iliac, aneurysm
Medical subject headings
Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovascular repairDevice

    Endovascular repair of aorto-iliac or iliac aneurysms using an iliac branch device (IBD)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from endoleak type I or III and patency of EIA and IIA on E-liac implantation side(s)

    Rate of patients that reach the primary endpoint

    Measured: 12 months

Secondary outcomes (17)

  1. Mortality

    Rate of all cause mortality in peri-operative periods

    Measured: 24 hours

  2. Survival rate

    Rate of survival

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

  3. Aneurysm size

    Rate of patients with decreasing, stable, increasing aneurysm size

    Measured: 12, 24, 36, 60 months

  4. Primary patency of EIA / IIA

    Rate of patients with primary patency of EIA / IIA

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

  5. Secondary patency of EIA / IIA

    Rate of patients with secondary patency of EIA / IIA

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

  6. Stent graft dislodgement

    Rate of patients with stent graft dislodgement

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

  7. Endoleak type I

    Rate of patients with infrarenal type Ia endoleak

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

  8. Endoleak type Ia in the CIA (isolated iliac aneurysm treatment)

    Rate of patients with infrarenal type Ia endoleak

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

  9. Endoleak type Ib in the CIA

    Rate of patients with endoleak type Ib in the CIA

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

  10. Endoleak type Ib in the EIA

    Rate of patients with endoleak type Ib in the EIA

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

  11. Endoleak type Ib in the IIA

    Rate of patients with endoleak type Ib in the IIA

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

  12. Endoleak type II

    Rate of patients with endoleak type II

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

  13. Endoleak type III

    Rate of patients with endoleak type III

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

  14. Stent fracture

    Rate of patients with stent fracture

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

  15. Reintervention

    Rate patients with reintervention after E-liac Stent Graft implantation

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

  16. Claudication

    Rate of patients with increasing, stable, decreasing claudication (walking distance without pain)

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

  17. Adverse Events

    Rate of patients with adverse events (product-related, procedure-related, aneurysm-related)

    Measured: prior to discharge / 30 days, 12, 24, 36, 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2018
  2. Study start15 Jul 2018
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion31 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03606083
Sponsor's protocol ID
PLIANTII
Acronym
PLIANTII
Status last verified
Apr 2025
First submitted
29 Jun 2018
Last updated
2 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Anton S, Wiedner M, Stahlberg E, Jacob F, Barkhausen J, Goltz JP. Initial Experience with the E-liac(R) Iliac Branch Device for the Endovascular Aortic Repair of Aorto-iliac Aneurysm. Cardiovasc Intervent Radiol. 2018 May;41(5):683-691. doi: 10.1007/s00270-017-1868-x. Epub 2018 Jan 3.

    PubMed 29299625

  • Mylonas SN, Rumenapf G, Schelzig H, Heckenkamp J, Youssef M, Schafer JP, Ahmad W, Brunkwall JS; E-liac Collaborative Group. A multicenter 12-month experience with a new iliac side-branched device for revascularization of hypogastric arteries. J Vasc Surg. 2016 Dec;64(6):1652-1659.e1. doi: 10.1016/j.jvs.2016.04.065. Epub 2016 Aug 1.

    PubMed 27492764

  • Oberhuber A, Deglise S, Richter O, Makaloski V, Bracale U, Isernia G, Tines R, Cappelli A, Dorweiler B, Brunkwall J; PLIANTII Study Collaboration. A Prospective, Multicentre Registry on Thirty Day and One Year Outcomes of the E-liac Stent Graft System in Patients with Unilateral or Bilateral Aorto-iliac or Iliac Aneurysms: The PLIANTII Study. Eur J Vasc Endovasc Surg. 2025 Jun;69(6):847-854. doi: 10.1016/j.ejvs.2025.02.029. Epub 2025 Feb 20.

    PubMed 39986435

Questions about this trial

What is this clinical trial studying?

An observational study of Vascular Aneurysm, run by JOTEC GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from endoleak type I or III and patency of EIA and IIA on E-liac implantation side(s) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03606083, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.

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